A Phase 3, Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain for Which Parenteral Opioid Therapy is Warranted

Trial Profile

A Phase 3, Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain for Which Parenteral Opioid Therapy is Warranted

Completed
Phase of Trial: Phase III

Latest Information Update: 22 May 2018

At a glance

  • Drugs Oliceridine (Primary)
  • Indications Pain; Postoperative pain
  • Focus Adverse reactions; Registrational
  • Acronyms ATHENA-1
  • Sponsors Trevena
  • Most Recent Events

    • 22 May 2018 According to a Trevena media release, efficacy, safety and tolerability data from 115 colorectal patients from this study were presented at the American Society of Colon and Rectal Surgeons 2018 Annual Scientific Meeting.
    • 07 Mar 2018 According to a Trevena media release, Company announced top-line results in November.
    • 07 Mar 2018 According to a Trevena media release,The Company anticipates the PDUFA date for the NDA will be November 2, 2018 and Company expects commercial launch of OLINVO in the first quarter of 2019 following DEA scheduling.
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